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History of Changes for Study: NCT01046331
Novel Influenza A (H1N1) Surveillance Registry
Latest version (submitted April 13, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 8, 2010 None (earliest Version on record)
2 November 9, 2010 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 April 13, 2016 References and Study Status
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Study NCT01046331
Submitted Date:  January 8, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: 688
Brief Title: Novel Influenza A (H1N1) Surveillance Registry
Official Title: Novel Influenza A (H1N1) Surveillance Registry
Secondary IDs: N01HR056179 [Other Grant/Funding Number: NIH Contract Number]
HSN268200536179C [Other Grant/Funding Number: NIH Contract Number]
Open or close this module Study Status
Record Verification: December 2009
Overall Status: Recruiting
Study Start: October 2009
Primary Completion:
Study Completion:
First Submitted: January 8, 2010
First Submitted that
Met QC Criteria:
January 8, 2010
First Posted: January 12, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 8, 2010
Last Update Posted: January 12, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The demographic characteristics, clinical features, course, and outcomes of severe H1N1 influenza infection requiring intensive care have not been defined rigorously and systematically. While the majority of patients in early reports of critically ill novel influenza A (H1N1) have respiratory involvement, up to 10-20% may present with non-respiratory organ failures, such as shock, seizures, or acute renal failure. The burden of disease and resource utilization of these patients remains largely unknown. The purpose of this surveillance registry is to characterize the demographics, clinical features, outcomes, and resource utilization of patients with H1N1 influenza infection who require intensive care.
Detailed Description:
Open or close this module Conditions
Conditions: Novel Influenza A
H1N1
Influenza
Keywords:
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective:
Biospecimen Retention:
Biospecimen Description:
Enrollment: 2000 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
Adult H1N1
Patients admitted to adult ICU with confirmed or suspected H1N1 Influence infection
Pediatric H1N1
Patients admitted to pediatric ICU with confirmed or suspected H1N1 Influenza infection
Open or close this module Outcome Measures
Open or close this module Eligibility
Study Population: Subjects admitted to adult or pediatric ICUs with suspected or confirmed Novel H1N1 Influenza infection.
Sampling Method: Non-Probability Sample
Minimum Age:
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Admission to an intensive care unit at a participating site with confirmed or suspected Novel H1N1 Influenza infection

Exclusion Criteria:

  • Influenza-like illness due to non-influenza disease and negative testing for influenza
Open or close this module Contacts/Locations
Central Contact Person: David Schoenfeld, PhD
Telephone: 617-726-6111
Email: dschoenfeld@partners.org
Study Officials: B. Taylor Thompson, MD
Principal Investigator
Massachusetts General Hospital
Adrienne G Randolph, MD, MSc
Principal Investigator
Boston Children's Hospital
Todd W Rice, MD, MSc
Principal Investigator
Vanderbilt University
Locations: United States, Alaska
Alaska Native Medical Center
[Recruiting]
Anchorage, Alaska, United States
Contact:Principal Investigator: Calle Gonzales, MD
The Children's Hospital at Providence
[Recruiting]
Anchorage, Alaska, United States
Contact:Principal Investigator: Barbara Coopes, MD
United States, Arizona
Phoenix Children's Hospital
[Recruiting]
Phoenix, Arizona, United States
Contact:Principal Investigator: David Tellez, MD
United States, Arkansas
Arkansas Children's Hiospital
[Recruiting]
Little Rock, Arkansas, United States
Contact:Principal Investigator: Ronald Sanders, MD
United States, California
University of San Francisco-Fresno Medical Center
[Recruiting]
Fresno, California, United States
Contact:Sub-Investigator: Michael Peterson, MD
Children's Hospital Los Angeles
[Recruiting]
Los Angeles, California, United States
Contact:Principal Investigator: Barry Markovitz, MD
Children's Hospital and Research Center Oakland
[Recruiting]
Oakland, California, United States
Contact:Principal Investigator: Heidi Flori, MD
Children's Hospital of Orange County
[Recruiting]
Orange, California, United States
Contact:Principal Investigator: Nick Anas, MD
University of California, Davis Medical Center
[Recruiting]
Sacramento, California, United States
Contact:Sub-Investigator: Timothy Albertson, MD, MPH, PhD
UCSF Children's Medical Center
[Recruiting]
San Francisco, California, United States
Contact:Principal Investigator: Anil Sapru, MD
UCSF-Moffitt Hospital
[Recruiting]
San Francisco, California, United States
Contact:Principal Investigator: Michael A. Matthay, MD
UCSF-San Francisco General Hospital
[Recruiting]
San Francisco, California, United States
Contact:Sub-Investigator: John Luce, MD
University of California, San Francisco (UCSF)-Moffitt Hospital
[Recruiting]
San Francisco, California, United States
Contact:Principal Investigator: Michael A. Matthay, MD
United States, Colorado
Denver's Children Hospital
[Recruiting]
Aurora, Colorado, United States
Contact:Principal Investigator: Angela Czaja, MD
Centura St. Anthony Central Hospital
[Recruiting]
Denver, Colorado, United States
Contact:Sub-Investigator: Tom Bost, MD
Denver Health Medical Center
[Recruiting]
Denver, Colorado, United States
Contact:Principal Investigator: Ivor Douglas, MD
Rose Medical Center
[Recruiting]
Denver, Colorado, United States
Contact:Sub-Investigator: Steve Frankel, MD
University of Colorado Health Sciences Center
[Recruiting]
Denver, Colorado, United States
Contact:Principal Investigator: Marc Moss, MD
United States, Connecticut
Connecticut Children's Medical Center
[Recruiting]
Hartford, Connecticut, United States
Contact:Principal Investigator: Christopher Carroll, MD
Yale-New Haven Children's Hospital
[Recruiting]
New Haven, Connecticut, United States
Contact:Principal Investigator: John Giuliano, MD
United States, District of Columbia
Children's National Medical Center
[Recruiting]
Washington, District of Columbia, United States
Contact:Principal Investigator: Angela Wratney, MD
Washington Hospital Center
[Recruiting]
Washington Dc, District of Columbia, United States
Contact:Sub-Investigator: Daniel Herr, MD
United States, Florida
Mayo Clinic at Jacksonville
[Recruiting]
Jacksonville, Florida, United States
Holt'z Children's Hospital
[Recruiting]
Miami, Florida, United States
Contact:Principal Investigator: Gwenn McLaughlin, MD
Miami Children's Hospital
[Recruiting]
Miami, Florida, United States
Contact:Principal Investigator: Keith Meyer, MD
United States, Georgia
Children's Healthcare of Atlanta at Egleston
[Recruiting]
Atlanta, Georgia, United States
Contact:Principal Investigator: Matthew Paden, MD
United States, Hawaii
Kapi'olani Center for Women and Children
[Recruiting]
Honolulu, Hawaii, United States
Contact:Principal Investigator: Rupert Chang, MD
United States, Illinois
Children's Memorial Hospital
[Recruiting]
Chicago, Illinois, United States
Contact:Principal Investigator: Denise Goodman, MD
United States, Kentucky
Kosair Children's Hospital
[Recruiting]
Louisville, Kentucky, United States
Contact:Principal Investigator: Vicki Montgomery, MD
United States, Louisiana
Earl K. Long Medical Center
[Recruiting]
Baton Rouge, Louisiana, United States
Contact:Sub-Investigator: Stephen Brierre, MD
Our Lady of the Lake Regional Medical Center
[Recruiting]
Baton Rouge, Louisiana, United States
Contact:Principal Investigator: Ben deBloisblanc, MD
Medical Center of Louisiana
[Recruiting]
New Orleans, Louisiana, United States
Contact:Principal Investigator: Ben deBoisblanc, MD
Ochsner Clinic Foundation
[Recruiting]
New Orleans, Louisiana, United States
Contact:Principal Investigator: Ben deBloisblanc, MD
Tulane University Health Sciences Center
[Recruiting]
New Orleans, Louisiana, United States
Contact:Sub-Investigator: Francesco Simeone, MD
United States, Maryland
Johns Hopkins Bayview Medical Center
[Recruiting]
Baltimore, Maryland, United States
Contact:Sub-Investigator: Jonathan Sevransky, MD
Johns Hopkins Children's Center
[Recruiting]
Baltimore, Maryland, United States
Contact:Principal Investigator: Melania Bembea, MD
Johns Hopkins Hospital
[Recruiting]
Baltimore, Maryland, United States
Contact:Principal Investigator: Roy Brower, MD
Union Memorial Hospital
[Recruiting]
Baltimore, Maryland, United States
Contact:Sub-Investigator: Peter Sloane, MD
University of Maryland Shock Trauma Center
[Recruiting]
Baltimore, Maryland, United States
Contact:Sub-Investigator: Carl Shanholtz, MD
United States, Massachusetts
Boston Medical Center
[Recruiting]
Boston, Massachusetts, United States
Children's Hospital Boston
[Recruiting]
Boston, Massachusetts, United States
Contact:Principal Investigator: Adrienne Randolph, MD
Baystate Medical Center
[Recruiting]
Springfield, Massachusetts, United States
Contact:Principal Investigator: Jay Steingrub, MD
United States, Michigan
Helen DeVos Children's Hospital
[Recruiting]
Grand Rapids, Michigan, United States
Contact:Principal Investigator: Raja Surrender, MD
United States, Minnesota
Children's Hospital and Clinics of Minnesota
[Recruiting]
Minneapolis, Minnesota, United States
Contact:Principal Investigator: Stephen Kurachek, MD
University of Minnesota Children's Hospital
[Recruiting]
Minneapolis, Minnesota, United States
Contact:Principal Investigator: Marie Steiner, MD
Rochester Methodist Hospital
[Recruiting]
Rochester, Minnesota, United States
Contact:Principal Investigator: Rolf Hubmayr, MD
St. Mary's Hospital, Mayo Clinic
[Recruiting]
Rochester, Minnesota, United States
Contact:Principal Investigator: Rolf Hubmayr, MD
United States, Missouri
SSM Cardinal Glennon Children's Medical Center
[Recruiting]
St. Louis, Missouri, United States
Contact:Principal Investigator: Jeremy Garrett, MD
St. Louis Children's Hospital
[Recruiting]
St. Louis, Missouri, United States
Contact:Principal Investigator: Allan Doctor, MD
United States, Nebraska
Children's Hospital of Nebraska
[Recruiting]
Omaha, Nebraska, United States
Contact:Principal Investigator: Ed Truemper, MD
United States, New Hampshire
Darthmouth-Hitchcock Medical Center
[Recruiting]
Lebanon, New Hampshire, United States
Contact:Principal Investigator: Daniel Levin, MD
United States, New York
Children's Hospital of Montefiore
[Recruiting]
Bronx, New York, United States
Contact:Principal Investigator: Chhabi Katyai, MD
University of Rochester Medical Center
[Recruiting]
Rocherster, New York, United States
Contact:Principal Investigator: Kate Ackerman, MD
United States, North Carolina
University of North Carolina
[Recruiting]
Chapel Hill, North Carolina, United States
Contact:Sub-Investigator: Shannon Carson, MD
Duke University Children's Hospital
[Recruiting]
Durham, North Carolina, United States
Contact:Principal Investigator: Ira Cheifetz, MD
Duke University Medical Center
[Recruiting]
Durham, North Carolina, United States
Contact:Principal Investigator: Neil MacIntyre, MD
Durham Regional Medical Center
[Recruiting]
Durham, North Carolina, United States
Contact:Sub-Investigator: Jaspal Singh, MD
Moses Cone Health System
[Recruiting]
Greensboro, North Carolina, United States
Contact:Sub-Investigator: Patrick Wright, MD
Wesley Long Community Hospital
[Recruiting]
Greensboro, North Carolina, United States
Contact:Sub-Investigator: Patrick Wright, MD
Wake Forest University Baptist Medical Center
[Recruiting]
Winston Salem, North Carolina, United States
Contact:Principal Investigator: R. Duncan Hite, MD
United States, Ohio
Cleveland Clinic Foundation
[Recruiting]
Cleveland, Ohio, United States
Contact:Principal Investigator: Herbert Wiedemann, MD
MetroHealth Medical Center
[Recruiting]
Cleveland, Ohio, United States
Contact:Sub-Investigator: Alfred Connors, MD
University Hospitals of Cleveland
[Recruiting]
Cleveland, Ohio, United States
Contact:Sub-Investigator: Jeffrey Kern, MD
Nationwide Children' Hospital
[Recruiting]
Columbus, Ohio, United States
Contact:Principal Investigator: Mark Hall, MD
United States, Oklahoma
Children's Hospital at St. Francis
[Recruiting]
Tulsa, Oklahoma, United States
Contact:Principal Investigator: Philip Barton, MD
United States, Oregon
Doernbecher Children's Hospital
[Recruiting]
Portland, Oregon, United States
Contact:Principal Investigator: Aileen Kirby, MD
United States, Pennsylvania
Penn State Children's Hospital
[Recruiting]
Hershey, Pennsylvania, United States
Contact:Principal Investigator: Neal Thomas, MD
The Children's Hospital of Philadelphia
[Recruiting]
Philadelphia, Pennsylvania, United States
Contact:Principal Investigator: Mark Helfar, MD
United States, Tennessee
Monroe Carell Children's Hospital at Vanderbilt
[Recruiting]
Nashville, Tennessee, United States
Contact:Principal Investigator: Rick Barr, MD, MSCI
Vanderbilt University Medical Center
[Recruiting]
Nashville, Tennessee, United States
Contact:Principal Investigator: Arthur Wheeler, MD
United States, Texas
Dell Children's Medical Center of Central Texas
[Recruiting]
Austin, Texas, United States
Contact:Principal Investigator: Renee Higgerson, MD
University of Texas Southwestern Children's Medical Center
[Recruiting]
Dallas, Texas, United States
Contact:Principal Investigator: Marita Thompson, MD
Baylor College of Medicine
[Recruiting]
Houston, Texas, United States
Contact:Sub-Investigator: Kalpalatha Guntupalli, MD
Texas Children's Hospital
[Recruiting]
Houston, Texas, United States
Contact:Principal Investigator: Laura Loftis, MD
United States, Utah
Intermountain Medical Center
[Recruiting]
Murray, Utah, United States
Contact:Principal Investigator: Alan Morris, MD
McKay-Dee Hospital
[Recruiting]
Ogden, Utah, United States
Contact:Sub-Investigator: Charles Lawton, MD
Utah Valley Regional Medical Center
[Recruiting]
Provo, Utah, United States
Contact:Sub-Investigator: Krishna Sundar, MD
LDS Hospital
[Recruiting]
Salt Lake City, Utah, United States
Contact:Principal Investigator: Alan Morris, MD
Primary Children's Medical Center
[Recruiting]
Salt Lake City, Utah, United States
Contact:Principal Investigator: Krow Ampofo, MD
United States, Virginia
University of Virginia Children's Medical Center
[Recruiting]
Charlottesville, Virginia, United States
Contact:Principal Investigator: Douglas Wilson, MD
University of Virginia Medical Center
[Recruiting]
Charlottesville, Virginia, United States
Contact:Sub-Investigator: Jonathon Truwit, MD
United States, Washington
Providence Hospital
[Recruiting]
Everett, Washington, United States
Harborview Medical Center
[Recruiting]
Seattle, Washington, United States
Contact:Principal Investigator: Leonard Hudson, MD
Seattle Children's Hospital
[Recruiting]
Seattle, Washington, United States
Contact:Principal Investigator: Jerry Zimmerman, MD
University of Washington
[Recruiting]
Seattle, Washington, United States
Contact:Sub-Investigator: Margaret Neff, MD
United States, Wisconsin
Children's Hospital of Wisconsin
[Recruiting]
Milwaukee, Wisconsin, United States
Contact:Principal Investigator: Rainer Gedeit, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links: Description: Related Info
Available IPD/Information:

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